Recall Z-1429-2026— Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Name: FDA recall Z-1429-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Class II · Ongoing

Class II FDA medical device recall by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, initiated 2026-02-06. It names one FDA 510(k) clearance: K232032. Product: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR. Reason: Software anomaly in the patient positioning system may result in positional discrepancy..

Recalling firm: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Classification: Class II
Status: Ongoing
Initiated: 2026-02-06
Firm location: Kashiwa, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K232032 — PROBEAT-FRHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha·cleared 2024-01-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Reason for recall

Software anomaly in the patient positioning system may result in positional discrepancy.

Data sourced from openFDA. This site is unofficial and independent of the FDA.